A Study to Establish the Safety and Tolerability of Zimura® (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:50 - Any
Updated:1/25/2019
Start Date:March 2015
End Date:October 2015

Use our guide to learn which trials are right for you!

A Phase 2a Study to Establish the Safety and Tolerability of Zimura® (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)

The objectives of this study are to evaluate the safety and tolerability of Zimura™
intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF)
therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).

Treatment experienced (Prior treatment with anti-VEGF monotherapy of ≥8 injections in the
previous twelve (12) months) subjects of either gender aged 50 years or above with a
diagnosis of IPCV, will receive 3 monthly (Q4W) intravitreal injections of Zimura™ (1 mg/eye)
in combination with anti-VEGF therapy (Avastin® 1.25 mg/eye or Lucentis® 0.5 mg/eye or Eylea®
2 mg/eye).

Safety endpoints include visual acuity loss (proportion of subjects with >15 letter loss at
Month 3), ophthalmic adverse events (AEs), systemic adverse events (AEs), change in total
retinal thickness (SD-OCT) at Month 3, regression and/or elimination of polyps at Month 3
compared to screening as measured by indocyanine green angiography (ICGA), and laboratory
values.

Inclusion Criteria:

- Subjects of either gender aged ≥ 50 years

- Diagnosis of IPCV

- Treatment-experienced defined as prior treatment with anti-VEGF mono therapy of ≥ 8
injections in the previous twelve (12) months

Exclusion Criteria:

- Any intraocular surgery or thermal laser within three (3) months of trial entry

- Any prior thermal laser in the macular region, regardless of indication

- Any ocular or periocular infection in the twelve (12) weeks prior to entry

- History of any of the following conditions or procedures in the study eye:
Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g.
trabeculectomy), glaucoma drainage device, corneal transplant

- Previous therapeutic radiation in the region of the study eye

- A diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy
and/or leakage from retinal vasculature in a subject with diabetes mellitus)
We found this trial at
1
site
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials